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Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF (RELAX-AHF-ASIA)

12 de junio de 2019 actualizado por: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo Controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

876

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Corea, república de
      • Busan, Corea, república de, 602739
        • Novartis Investigative Site
      • Gwangju, Corea, república de, 61469
        • Novartis Investigative Site
      • Incheon, Corea, república de, 405 760
        • Novartis Investigative Site
      • Seoul, Corea, república de, 03080
        • Novartis Investigative Site
      • Seoul, Corea, república de, 03722
        • Novartis Investigative Site
      • Seoul, Corea, república de, 02841
        • Novartis Investigative Site
    • Bucheon Si
      • Gyeonggi do, Bucheon Si, Corea, república de, 422-711
        • Novartis Investigative Site
    • Chungcheongbuk Do
      • Cheongju si, Chungcheongbuk Do, Corea, república de, 28644
        • Novartis Investigative Site
    • Gangwon-do
      • Wonju, Gangwon-do, Corea, república de, 26427
        • Novartis Investigative Site
    • Gyeonggi Do
      • Bundang Gu, Gyeonggi Do, Corea, república de, 13620
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Corea, república de, 05505
        • Novartis Investigative Site
      • Seoul, Korea, Corea, república de, 06351
        • Novartis Investigative Site
      • Seoul, Korea, Corea, república de, 08308
        • Novartis Investigative Site
    • Seocho Gu
      • Seoul, Seocho Gu, Corea, república de, 06591
        • Novartis Investigative Site
  • Filipinas
      • Makati City, Filipinas, 1229
        • Novartis Investigative Site
      • Manila, Filipinas, 1003
        • Novartis Investigative Site
      • Pasig City, Filipinas, 1605
        • Novartis Investigative Site
      • Quezon City, Filipinas, 1102
        • Novartis Investigative Site
      • Quezon City, Filipinas, 1113
        • Novartis Investigative Site
      • San Juan City, Filipinas, 1500
        • Novartis Investigative Site
    • Manila
      • Quezon City, Manila, Filipinas, 1100
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Filipinas, 1000
        • Novartis Investigative Site
  • India
      • Rajasthan, India, 334003
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
        • Novartis Investigative Site
      • Vadodara, Gujarat, India, 390022
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Novartis Investigative Site
      • Nagpur, Maharashtra, India, 440012
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600101
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Novartis Investigative Site
  • Japón
      • Osaka, Japón, 534-0021
        • Novartis Investigative Site
      • Saitama, Japón, 330 8503
        • Novartis Investigative Site
    • Aichi
      • Nagakute-city, Aichi, Japón, 480-1195
        • Novartis Investigative Site
      • Seto-city, Aichi, Japón, 489-8642
        • Novartis Investigative Site
    • Chiba
      • Kamogawa-city, Chiba, Japón, 2968602
        • Novartis Investigative Site
    • Ehime
      • Saijo-city, Ehime, Japón, 793-0027
        • Novartis Investigative Site
    • Fukuka
      • Chikushino-city, Fukuka, Japón, 818-8516
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japón, 810-0001
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japón, 811-0213
        • Novartis Investigative Site
      • Fukuoka-city, Fukuoka, Japón, 815-8588
        • Novartis Investigative Site
      • Iizuka-city, Fukuoka, Japón, 820-8505
        • Novartis Investigative Site
      • Kurume-city, Fukuoka, Japón, 830-8543
        • Novartis Investigative Site
      • Kurume-city, Fukuoka, Japón, 830-8577
        • Novartis Investigative Site
    • Gifu
      • Ogaki-city, Gifu, Japón, 503-8502
        • Novartis Investigative Site
    • Hokkaido
      • Kushiro-city, Hokkaido, Japón, 085-0062
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japón, 006-8555
        • Novartis Investigative Site
    • Hyogo
      • Amagasaki city, Hyogo, Japón, 660 8550
        • Novartis Investigative Site
      • Kobe-City, Hyogo, Japón, 654-0155
        • Novartis Investigative Site
    • Ibaraki
      • Mito-city, Ibaraki, Japón, 311-4198
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japón, 920 8650
        • Novartis Investigative Site
    • Kagawa
      • Kanonji-city, Kagawa, Japón, 769-1695
        • Novartis Investigative Site
      • Takamatsu city, Kagawa, Japón, 760 8557
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki-city, Kanagawa, Japón, 211-8533
        • Novartis Investigative Site
      • Yokohama city, Kanagawa, Japón, 232 0024
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japón, 236 0051
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japón, 227-8501
        • Novartis Investigative Site
      • Yokohama-city, Kanagawa, Japón, 231-8682
        • Novartis Investigative Site
    • Kochi
      • Kochi city, Kochi, Japón, 781 8555
        • Novartis Investigative Site
    • Kumamoto
      • Kumamoto-city, Kumamoto, Japón, 861-4193
        • Novartis Investigative Site
      • Yatsushiro-city, Kumamoto, Japón, 866-8660
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japón, 607-8062
        • Novartis Investigative Site
      • Uji-city, Kyoto, Japón, 611-0042
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, Japón, 981-3133
        • Novartis Investigative Site
    • Nagano
      • Nakano-city, Nagano, Japón, 383-8505
        • Novartis Investigative Site
      • Saku-city, Nagano, Japón, 3850051
        • Novartis Investigative Site
      • Ueda-city, Nagano, Japón, 386-8610
        • Novartis Investigative Site
    • Niigata
      • Niigata-city, Niigata, Japón, 950-1197
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Japón, 540-0006
        • Novartis Investigative Site
    • Saitama
      • Kawaguchi-city, Saitama, Japón, 333-0842
        • Novartis Investigative Site
      • Sayama-city, Saitama, Japón, 350-1323
        • Novartis Investigative Site
      • Wako-city, Saitama, Japón, 351-0102
        • Novartis Investigative Site
    • Shiga
      • Kusatsu city, Shiga, Japón, 525 8585
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu-city, Shizuoka, Japón, 430-8558
        • Novartis Investigative Site
      • Kakegawa-city, Shizuoka, Japón, 436-8555
        • Novartis Investigative Site
    • Tokyo
      • Akishima-city, Tokyo, Japón, 196-0003
        • Novartis Investigative Site
      • Chuo ku, Tokyo, Japón, 104-8560
        • Novartis Investigative Site
      • Hachioji-city, Tokyo, Japón, 192-0918
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, Japón, 173-8610
        • Novartis Investigative Site
      • Musashino-city, Tokyo, Japón, 180-8610
        • Novartis Investigative Site
      • Shinagawa ku, Tokyo, Japón, 141 8625
        • Novartis Investigative Site
      • Shinagawa-ku, Tokyo, Japón, 142-8666
        • Novartis Investigative Site
    • Wakayama
      • Tanabe-city, Wakayama, Japón, 646-8558
        • Novartis Investigative Site
  • Jordán
      • Amman, Jordán, 11183
        • Novartis Investigative Site
      • Amman, Jordán, 11184
        • Novartis Investigative Site
    • JOR
      • Amman, JOR, Jordán, 11152
        • Novartis Investigative Site
  • Líbano
      • Ashrafieh, Líbano, 166830
        • Novartis Investigative Site
      • Beirut, Líbano, 1107 2020
        • Novartis Investigative Site
      • Beirut, Líbano
        • Novartis Investigative Site
      • Hazmieh, Líbano, 470
        • Novartis Investigative Site
  • Malasia
      • Kuala Lumpur, Malasia, 59100
        • Novartis Investigative Site
      • Kuala Lumpur, Malasia, 50400
        • Novartis Investigative Site
    • MYS
      • Kuala Lumpur, MYS, Malasia, 56000
        • Novartis Investigative Site
    • Sabah
      • Kota Kinabalu, Sabah, Malasia, 88300
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malasia, 94300
        • Novartis Investigative Site
    • Selangor Darul Ehsan
      • Kuala Lumpur, Selangor Darul Ehsan, Malasia, 43000
        • Novartis Investigative Site
      • Sungai Buloh, Selangor Darul Ehsan, Malasia, 47000
        • Novartis Investigative Site
  • Porcelana
      • Beijing, Porcelana, 100050
        • Novartis Investigative Site
      • Chongqing, Porcelana, 400037
        • Novartis Investigative Site
      • Shanghai City, Porcelana
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, Porcelana, 100039
        • Novartis Investigative Site
      • Beijing, Beijing, Porcelana, 100037
        • Novartis Investigative Site
    • Gansu
      • Lanzhou, Gansu, Porcelana, 730030
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 51000
        • Novartis Investigative Site
      • Guangzhou, Guangdong, Porcelana, 510515
        • Novartis Investigative Site
    • Jiangsu
      • Suzhou, Jiangsu, Porcelana, 215006
        • Novartis Investigative Site
      • Yangzhou, Jiangsu, Porcelana
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110000
        • Novartis Investigative Site
      • Shenyang, Liaoning, Porcelana, 110003
        • Novartis Investigative Site
    • Shanghai
      • Jinshan, Shanghai, Porcelana, 201508
        • Novartis Investigative Site
      • Shanghai, Shanghai, Porcelana, 200032
        • Novartis Investigative Site
    • Shanxi
      • Xian, Shanxi, Porcelana, 710061
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, Porcelana, 300121
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310013
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, Porcelana, 325000
        • Novartis Investigative Site
  • Singapur
      • Singapore, Singapur, 169609
        • Novartis Investigative Site
      • Singapore, Singapur, 117549
        • Novartis Investigative Site
  • Tailandia
      • Bangkok, Tailandia, 10330
        • Novartis Investigative Site
      • Bangkok, Tailandia, 10700
        • Novartis Investigative Site
      • Bangkok, Tailandia, 10400
        • Novartis Investigative Site
      • Chiang Mai, Tailandia, 50200
        • Novartis Investigative Site
      • Muang, Tailandia, 40002
        • Novartis Investigative Site
    • Hat Yai
      • Songkhla, Hat Yai, Tailandia, 90110
        • Novartis Investigative Site
  • Taiwán
      • Changhua, Taiwán, 50006
        • Novartis Investigative Site
      • Kaohsiung, Taiwán, 80756
        • Novartis Investigative Site
      • Kaohsiung City, Taiwán, 83301
        • Novartis Investigative Site
      • New Taipei, Taiwán, 22060
        • Novartis Investigative Site
      • Taichung, Taiwán, 40447
        • Novartis Investigative Site
      • Taipei, Taiwán, 10002
        • Novartis Investigative Site
      • Taipei, Taiwán, 11217
        • Novartis Investigative Site
      • Taipei, Taiwán, 10449
        • Novartis Investigative Site
      • Taoyuan, Taiwán, 33305
        • Novartis Investigative Site
      • Yilan, Taiwán, 26058
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or female ≥ 18 years of age, with body weight ≤160 kg

  • Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and at the end of screening:

    • Persistent dyspnea at rest or with minimal exertion at screening and at the time of randomization
    • Pulmonary congestion on chest radiograph
    • Brain natriuretic peptide (BNP) ≥500 pg/mL or NT-proBNP ≥2,000 pg/mL
  • Systolic BP ≥125 mmHg at the start and at the end of screening
  • Able to be randomized within 16 hours from presentation to the hospital, including the emergency department and outpatient clinic
  • Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
  • Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of ≥ 25 and ≤75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula (or modified sMDRD formula according to specific ethnic groups and local practice guidelines).

Exclusion Criteria:

  • Dyspnea primarily due to non-cardiac causes
  • Temperature >38.5°C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).

  • Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment

    *Patients with systolic blood pressure >180 mmHg at the end of screening

  • AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of >130 beats per minute

  • Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin > 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).

    *Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis

  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Patients will receive continuous intravenous infusion of matching placebo serelaxin for 48 hours.
Droga: Placebo
Infusión intravenosa
Otro: Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Experimental: Serelaxin
Patients will receive continuous intravenous infusion of serelaxin(30 µg/kg/day) for 48 hours.
Otro: Standard of CareTherapy
This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
Droga: Serelaxina
Infusión intravenosa

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.
Periodo de tiempo: through day 5
The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.
through day 5

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to WHF
Periodo de tiempo: Through Day 5
Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).
Through Day 5
Time to CV Death
Periodo de tiempo: Through Day 180
analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).
Through Day 180
Time to All-cause Death
Periodo de tiempo: Through Day 180
Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).
Through Day 180
Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days
Periodo de tiempo: Through Day 5
Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale
Through Day 5
Dyspnea by VAS-AUC Changes
Periodo de tiempo: Through Day 5
Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours
Through Day 5
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Periodo de tiempo: Up to day 30
Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day
Up to day 30
Renal Dysfunction and Prevention of Worsening of Renal Function
Periodo de tiempo: Through Day 5
number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5
Through Day 5
Time to Re-hospitalization Due to Heart Failure and Renal Impairment
Periodo de tiempo: Through Day 180
Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment
Through Day 180
Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure
Periodo de tiempo: Through Day 180
Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).
Through Day 180
Time to In-hospital Worsening Heart Failure Through Day 5
Periodo de tiempo: Through Day 5
Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.
Through Day 5
Use of Loop Diuretic and Vasoactive Agents
Periodo de tiempo: Through Day 5
Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5
Through Day 5
Change From Baseline in Cardio-renal Biomarkers
Periodo de tiempo: Day 2 and Day 5
Day 2 and Day 5
Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.
Periodo de tiempo: For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.
To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.
For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de marzo de 2014

Finalización primaria (Actual)

27 de marzo de 2017

Finalización del estudio (Actual)

16 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2013

Primero enviado que cumplió con los criterios de control de calidad

9 de diciembre de 2013

Publicado por primera vez (Estimar)

11 de diciembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de junio de 2019

Última verificación

1 de junio de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CRLX030A2302

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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